ReportontheDeliberationResults
March3,2014
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau
MinistryofHealth,LabourandWelfare
[Brandname](a)SamscaTablets7.5mg
(b)SamscaTablets15mg
(c)SamscaTablets30mg
[Non-proprietaryname]Tolvaptan(JAN*)
[Nameofapplicant]OtsukaPharmaceuticalCo.,Ltd.
[Dateofapplication]May30,2013
[Resultsofdeliberation]
InthemeetingheldonFebruary24,2014,theFirstCommitteeonNewDrugsconcludedthatapplications
forpartialchangesforSamscaTablets7.5mgand15mgandanewdrugapplicationforSamscaTablets30
mgmaybeapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairsDepartmentof
thePharmaceuticalAffairsandFoodSanitationCouncil.
SinceSamscahasbeendesignatedasanorphandrugfortheindicationofautosomaldominantpolycystic
kidneydisease,itsre-examinationperiodis10yearsfortheindicationandthedosageandadministration
proposedinthecurrentapplication.WithrespecttoSamscaTablets30mg,thedrugproductisclassifiedas
apowerfuldrug,andtheproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.
[Conditionsforapproval]
(a)and(b)tobeusedforslowingtheprogressionofautosomaldominantpolycystickidneydiseasein
patientswithanincreasedkidneyvolumeandarapidrateofkidneyvolumeincrease,
Theapplicantisrequiredto:
1.TakenecessarymeasurespriortomarketingtoensurethatSamscaisprescribedonlybyphysician